PatientsVille.com

Acute Mountain Sickness research study

What is the primary objective of this study?

The study is examining if an over-the-counter device (Theravent) worn while sleeping can
reduce acute mountain sickness upon awakening in a high altitude trekking population.

Who is eligible to participate?

Inclusion Criteria:
- ages 18-65
- Lake Louise Score (LLS) of < 3
- Have not taken NSAIDs, acetazolamide, or corticosteroids in the prior week
- Have not traveled above 4200 m in the prior week.
- First night in Pheriche or Dingboche
Exclusion Criteria:
- Unable to read the consent form
- Taken NSAIDs, acetazolamide, or corticosteroids in the week prior to study enrollment.
- Hazardous medical conditions which precludes the ability to tolerate the experimental
device.
- Pregnancy or suspected pregnancy.
- Participants who are younger than 18 years of age and more than 65.
- Travel to or above 4200m in the preceding week.
- Diagnosis of AMS upon enrollment (LLS ≥3 with symptoms of headache)
- Previously diagnosed obstructive sleep apnea
- Current symptoms of nasal congestion, rhinorrhea, sinusitis, upper respiratory
infection, asthma, COPD exacerbation, pneumonia, bronchitis, or other disease of the
respiratory tract.

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Device:Theraventnasal EPAP device

Device:ControlSham device without EPAP

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Discuss Promethazine

If you think you may have a medical emergency, call your doctor or 911 immediately.

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